Despite the global advances in therapies for CLL/SLL patients, treatment options remain limited in the Asia-Pacific region and especially for difficult-to-treat R/R patients. In China, R/R CLL/SLL patients that do not respond to traditional chemotherapy are limited to rituximab or lenalidomide/thalidomide containing regimens. The aim of this trial was to evaluate the efficacy and safety of ibrutinib versus rituximab for the treatment of R/R CLL/SLL. The primary endpoints of the study were investigator-assessed progression-free survival (PFS), while secondary endpoints included overall response rate (ORR), overall survival (OS), and safety.

Safety

Overall incidence of adverse events (AEs) was similar between ibrutinib and rituximab and was not exposure-adjusted

Ibrutinib-related most common AEs: diarrhea and platelet count decrease

Rituximab-related most common AEs: neutrophil count and platelet count decrease

Grade ≥3 AEs were reported in 82.7% of ibrutinib-treated patients and 59.6% of rituximab-treatment patients

Incidence of bleeding AEs was 28.8% in the ibrutinib arm and 3.8% in the rituximab arm

Major haemorrhage events occurred in n = 3 (2.9%) patients in the ibrutinib arm and n = 1 (1.9%) in the rituximab arm

The results of this phase III clinical trial indicate the superiority of ibrutinib over rituximab for the treatment of R/R CLL/SLL patients in the Asia-Pacific region. With similarly acceptable safety profiles, ibrutinib improved PFS, ORR and OS, when compared to rituximab treatment. According to the authors, these results are consistent with other global studies, indicating that ibrutinib’s efficacy and safety over rituximab is comparable to the values observed for the general population.

Dec 8, 2016

May 17, 2017

Professional society

The European Lymphoma Institute is comprised of a network of top European specialists in the field of lymphoma who are dedicated to research, training and education. Together they look to define strategies to analyse and characterize lymphoma and its common diagnostic procedures and therapeutic standards, as well as to facilitate clinical and fundamental research. This all results in the advancement of lymphoma research and it guarantees equal access for all patients to the best possible care.